QUIZ #2: Current GMP* Issues in Manufacturing

Answer each of the following questions with TRUE or FALSE. Good luck!

  1. When verifying that the quantity of raw material weighed for a batch is correct, it is sufficient for the second operator to confirm the final weight of the material displayed on the balance.

  2. Laboratory records should include information regarding the date each sample was received for testing.

  3. As long as a piece of critical equipment is periodically examined by the operators who know and use it, a formalized maintenance and calibration program is not necessary.

  4. A monetary fine is the most serious action the FDA can take against a company that has violated the cGMPs.

  5. A monthly testing program to assess the presence of sanitizing agents in finished product is an acceptable replacement for cleaning validation, as long as cleaning agent residuals are not detected in any of the monthly tests.

  6. A product failure investigation is mandatory if a laboratory test result is out-of-specification and cannot be shown to be the result of laboratory error.

  7. During a routine inspection of an ethical pharmaceutical firm, the FDA can require you to present any documentation it so chooses.

  8. It is only necessary to record withdrawals from a raw material's inventory if it is an active ingredient.

  9. As long as the product is non-sterile, it is unnecessary to validate the length of time it may remain idle in a batching tank before further processing.

  10. Annual reviews must include an evaluation of every batch of every product manufactured by a company.

*21 CFR Part 211 - Current Good Manufacturing Practices for Finished Pharmaceuticals

How did you do? After you have taken the Quiz, request the answers via E-mail from accureg@regulatory.com. If you include your address, we'll send you a pocket book of the GMPs for Medical Devices or for finished Pharmaceuticals!

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